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Clinical Data Management Lead

hace 1 semana


Buenos Aires, Buenos Aires C.F., Argentina MSD A tiempo completo

MSD Overview

Career Description

About the Role

The Lead Clinical Database Testing Analyst at MSD is responsible for creating and executing Quality Control (QC) testing and User Acceptance Testing (UAT) procedures for electronic data capture (EDC) systems. This includes internet based EDC, electronic devices, electronic diaries, IVRS/IWRS, etc., along with reporting and documenting testing results. The individual will also be responsible for writing standard and trial specific test scripts, as well as providing peer review of CDT documentation. All in compliance with our Company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Key Responsibilities

The primary activities include:

  1. Responsible for the creation/modification/execution of standard and trial specific test scripts and record test data and test results. Responsible for the creation of Test Plans and Test Summary documentation. Responsible for the facilitation and coordination of testing activities related to the tool/system being tested. Responsible for the triaging and categorization of issues identified during UAT.
  2. May support data management process owner.
  3. Is a subject matter expert on CDT process, may be responsible for the updating and maintenance of CDT SOPs and supporting documentation.
  4. Should continually monitor the process looking for opportunities to improve the current process; to improve efficiency and effectiveness of the CDT group, additionally the person should implement changes as appropriate.
  5. May be assigned to lead or participate in cross functional technical and/or process improvement projects.
  6. As SME, the person may participate in the development of job specific training material and deliver training material as needed to the staff.
  7. May be assigned to a lead role for larger, and more complex or higher risk clinical trial programs, to ensure consistency across teams.